Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients

NCT07507409 | Not Yet Recruiting Phase 4 DMC FDA Device

• 1 other identifier: 25-277
• Study Type: interventional
• Target: 401
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if a new method of closing the breastbone after heart bypass surgery can improve healing and reduce complications in adults undergoing coronary artery bypass graft (CABG) surgery. The main questions it aims to answer are: Does this new closure method reduce infections and wound reopening? Does it improve healing, recovery, and overall patient outcomes? Researchers will compare patients who receive the new closure method to past patients who received the standard method to see if outcomes are better. Participants will: Receive the new closure method during their surgery (as part of standard care) Be followed during their normal recovery up to their 6-week follow-up visit Complete a short quality-of-life questionnaire (about 10 minutes) Have their recovery assessed, including healing, complications, and hospital use Researchers will also look at quality of life, heart complications, hospital readmissions, antibiotic use, scar appearance, and overall costs to understand the full impact of the new method.

Conditions

Cardiovascular Disease; Surgical Site Infection; Mediastinitis; Superficial Sternal Wound Infection

Keywords

STRATAFIX; DERMABOND; Sternal Closure; Suture; CABG

Outcome Measures

Primary Outcomes (1)

• Incidence of Sternal Wound Complications (Composite Endpoint)

  The primary outcome is a composite measure of treatment success or failure. A participant is considered a success only if they experience none of the following: Deep Sternal Wound Infection (DSWI), Superficial Sternal Wound Infection (SSWI), general Surgical Site Infection (SSI), or Sternal Dehiscence (SD). A participant is considered a failure if any one of these complications occurs. Sternal wound sites will be classified by blinded personnel using the Centers for Disease Control and Prevention (CDC) 4-level classification system. Sternal Dehiscence (SD) will be determined via a visual assessment by a cardiac surgeon and recorded as a binary result (yes or no).

  6 weeks post-operatively

Study Arms (1)

STRATAFIX™ and DERMABOND™ PRINEO™ Intervention Group

EXPERIMENTAL

This experimental arm evaluates a dual-component sternal closure strategy in 401 patients undergoing CABG surgery. The intervention replaces traditional non-barbed sutures with a combination of STRATAFIX™ barbed sutures and DERMABOND™ PRINEO™ mesh-based adhesive.

Device: Knotless Barbed Sutures; Device: Mesh-based Topical Skin Adhesive

Interventions

Knotless Barbed Sutures DEVICE

This intervention replaces traditional non-barbed, knotted sutures with a specialized knotless and adhesive system. The strategy is characterized by the following layer-specific applications: Deep Tissue (Presternal Fascia): Application of STRATAFIX™ Symmetric barbed sutures. Subcutaneous and Subcuticular Layers: Use of STRATAFIX™ Spiral MONOCRYL™ Plus and/or STRATAFIX™ Spiral PDS™ Plus. These sutures feature an antibacterial triclosan coating designed to reduce the risk of surgical site infections.

Also known as: STRATAFIX™ Symmetric barbed sutures, STRATAFIX™ Spiral MONOCRYL™ Plus, STRATAFIX™ Spiral PDS™ Plus

STRATAFIX™ and DERMABOND™ PRINEO™ Intervention Group

Mesh-based Topical Skin Adhesive DEVICE

Skin Surface: Final closure using the DERMABOND™ PRINEO™ system, which combines 2-octyl cyanoacrylate topical adhesive with a self-adhesive polymer mesh tape.

Also known as: DERMABOND™ PRINEO™

STRATAFIX™ and DERMABOND™ PRINEO™ Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients aged 18 years and older undergoing CABG surgery.

You may not qualify if:

• Patients who refuse to participate in the trial.
• Patients who do not read or speak English.
• Patient with allergy to surgical adhesives or sutures

Sponsors & Collaborators

• Unity Health Toronto: lead
• Johnson & Johnson: collaborator

Related Publications (14)

• Krishnamoorthy B, Shepherd N, Critchley WR, Nair J, Devan N, Nasir A, Barnard JB, Venkateswaran RV, Waterworth PD, Fildes JE, Yonan N. A randomized study comparing traditional monofilament knotted sutures with barbed knotless sutures for donor leg wound closure in coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2016 Feb;22(2):161-7. doi: 10.1093/icvts/ivv314. Epub 2015 Nov 20.

  PMID: 26590381 BACKGROUND

• Haenen, F. W. N., Guy, T. S. & Rodrigus, I. Knotless Closure of the Cardiac Venous Cannulation Site Using Barbed Suture: A First Step in Including Barbed Sutures in our Cardiac Surgery Practice. Surg. Case Rep. 2021, 1-4 (2021).

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• EQ-5D-5L. EuroQol https://euroqol.org/information-and-support/euroqol-instruments/eq-5d5l/.

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• Herman TF, Popowicz P, Bordoni B. Wound Classification. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554456/

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• Lemaignen A, Birgand G, Ghodhbane W, Alkhoder S, Lolom I, Belorgey S, Lescure FX, Armand-Lefevre L, Raffoul R, Dilly MP, Nataf P, Lucet JC. Sternal wound infection after cardiac surgery: incidence and risk factors according to clinical presentation. Clin Microbiol Infect. 2015 Jul;21(7):674.e11-8. doi: 10.1016/j.cmi.2015.03.025. Epub 2015 Apr 14.

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• Haenen FW, Van Oostende C, Allegaert M, Round KJ, Rosen JL, Guy ST, Rodrigus I. Prosthesis-prosthesis anastomosis using barbed sutures compared to conventional sutures under high, long-term pressure; in vitro extracorporeal circulation setup. Perfusion. 2024 Apr;39(3):571-577. doi: 10.1177/02676591231153539. Epub 2023 Jan 24.

  PMID: 36691745 BACKGROUND

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  PMID: 27005688 BACKGROUND

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• Song Y, Chu W, Sun J, Liu X, Zhu H, Yu H, Shen C. Review on risk factors, classification, and treatment of sternal wound infection. J Cardiothorac Surg. 2023 May 19;18(1):184. doi: 10.1186/s13019-023-02228-y.

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• Reser D, Caliskan E, Tolboom H, Guidotti A, Maisano F. Median sternotomy. Multimed Man Cardiothorac Surg. 2015 Jul 17;2015:mmv017. doi: 10.1093/mmcts/mmv017. Print 2015.

  PMID: 26188337 BACKGROUND

• Canada, P. H. A. of. Heart Disease in Canada. https://www.canada.ca/en/publichealth/services/publications/diseases-conditions/heart-disease-canada.html (2017).

  BACKGROUND

• Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

  PMID: 33309175 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Surgical Wound Infection; Mediastinitis

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: All personnel involved in data collection and the grading of sternal wound sites will be blinded to the treatment parameters to reduce bias.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-center, single-arm, non-randomized controlled trial designed to evaluate a novel sternal closure technique. The study model follows a prospective intervention with a retrospective comparison to historical data. The trial consists of a single treatment arm where all 401 participants receive the combination of STRATAFIX™ barbed sutures and DERMABOND™ PRINEO™ mesh-based adhesive. The intervention group will be compared against historic controls from the St. Michael's Hospital database. Recruitment and follow-up are expected to span 18 months, followed by 6 months of data analysis and manuscript preparation.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-03